Senior Associate Quality Control, Sample Management and Stability (Lab Support)

Amgen Inc.

3.6

(9)

Holly Springs, NC

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-189509

    Position summary

    ly feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

    Senior Associate Quality Control, Sample Management and Stability

    Live!

    What you will do

    Let's do this. Let's change the world. In this vital role you will be responsible for supporting the Quality Control Laboratory start up as a member of the QC Support Team. Responsibilities will include Sample management and Stability lab setup, validation of laboratory electronic systems and equipment, writing procedures and reports and ownership of QC Quality Records (Change controls, Deviations/CAPAs). Role may involve travel to support method or knowledge transfers. The Senior Associate QC Support will initially report to the Director of Quality Control. This individual will provide technical leadership in the QC Sample Management and Stability Laboratory. This role will support site start up and then transition to support manufacturing operations, and as such some extended hours, shift and weekend work may be vital.

    Under minimal direction, the successful candidate will support the startup of the QC organization by:

    • Lead the QC Support team by developing/maintaining processes and procedures for sample handling and storage.

    • Assist in the development cGMP system for incoming and outgoing samples.

    • Assist in the development of cGMP system for stability samples. Preparing protocols and defining the process by which to stage/load samples and handle pulls.

    • Develop/oversee monitoring system for sample and stability storage units.

    • Own and handle Deviation, CAPA and Change Control records to support Quality Control.

    • Work collaboratively with site teams to establish work order and PM system for laboratory equipment.

    • Review validation documents to support equipment and computerized system onboarding for sample management lab.

    • Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, technical assessments, microorganism assessments.

    • Assist with procurement activities for consumables and critical reagents for lab start up.

    • Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.

    • Support routine activities over the weekends and public holidays as required.

    Win!

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The quality control professional we seek is a effective leader with these qualifications.

    Basic Qualifications:

    • High school/GED + 4 years of Quality experience OR

    • Associate's + 2 years of Quality experience OR

    • Bachelor's + 6 months of Quality experience OR

    • Master's

    Preferred Qualifications:

    • Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.

    • 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.

    • Proficient in the use of LIMS & LMES/CIMS.

    • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.

    • Strong written and verbal communication skills including technical writing and presentation.

    • Experience with equipment and method validation, verification, and transfer including the change control process.

    • Interact effectively with variety of communication and working styles and ability to work well in teams.

    Thrive!

    What you can expect of us

    As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

    In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

    Apply now for a career that defies imagination

    Objects in your future are closer than they appear. Join us.
    careers.amgen.com

    Salary Range
    74,836.00 USD - 90,945.00 USD

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging